MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING manufactured by Nova Biomedical Corporation.
[184517044]
Upon pt's arrival to ed. Pt's blood glucose (bg) level checked using glucometer. Bg on glucometer read 47. Pt treated with d50 per emergency dept provider by primary rn 10 minutes later. Comprehensive metabolic panel collected immediately after bg was checked with glucometer, resulted and showed glucose to be 75. To confirm, 2 hours later glucose confirmatory done within 5 minutes of blood glucose fingerstick to show glucose of 85. Glucometer showed 60 from fingerstick. Point of care technician (poct) called. Per poct, ok to take glucometer out of service and call biomed. Charge notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9866689 |
| MDR Report Key | 9866689 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-28 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING |
| Product Code | PZI |
| Date Received | 2020-03-23 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVA BIOMEDICAL CORPORATION |
| Manufacturer Address | 200 PROSPECT ST WALTHAM MA 02454 US 02454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |